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New light therapy takes on stubborn toenail fungus

NCT ID NCT03098342

Disease control Sponsor: Chulalongkorn University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two treatments for toenail fungus in 27 Asian adults: a light-activated dye (methylene blue photodynamic therapy) and a medicated nail polish (amorolfine). The goal was to see which worked better and was safer. Participants received either the light treatment or the polish, and doctors used special photos to measure improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylene blue (used in photodynamic therapy) and amorolfine nail lacquer
What this could lead to
If successful, this could offer a new, non-drug treatment option for stubborn toenail fungus, potentially with fewer side effects than long-term antifungal pills.
What could go wrong
This is a small, completed study with only 27 participants, so results may not apply to everyone. Photodynamic therapy requires multiple clinic visits and may cause temporary pain or redness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Jun 2017

Finished

Jan 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically * Clinical signs of onychomycosis as following: * Discoloration * Dystrophy of nail plate * Subungual hyperkeratosis * Onycholysis * Confirmed by: * Positive culture of dermatophyte or non-dermatophyte (must be isolated from sequential specimens) and/or * Positive microscopic evidence\* * \*any of these methods, direct microscopy (KOH preparation), nail plate culture on Sabouraud's dextrose agar (SDA), histopathological examination of nail clippings using PAS staining (HPE-PAS), histopathological examination of nail clippings using GMS staining (HPE-GMS), polymerase chain reaction Exclusion Criteria: * Those with nail changes because of skin disease or associated systemic diseases * Pregnancy or lactating woman * Those who are allergic to amorolfine, methylene blue * Those who are photosensitive to visible light * Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.

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Conditions

The condition(s) this trial relates to.

tinea unguium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Onychomycosis of toenail

Contacts and locations

Locations

  • King Chulalongkorn Memorial Hospital

    Bangkok, Bangkok, 10330, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.